346550b9-d2ba-184e-e063-6394a90a591a

SPL v1
SPL
SPL Set ID 346550b9-d2ba-184e-e063-6394a90a591a
Route
topical
Published
Effective Date 2025-05-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
lidocaine (4 mg)
Inactive Ingredients
polyquaternium-7

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-05-05

Description

DRUG FACTS


Medication Information

Warnings and Precautions

For external use only

Active Ingredient

lIDOCAINE 4%

Indications and Usage

Temporarily relieves minor pain

Dosage and Administration

Adults and children 12 years of age and over:

  • Clean and dry the affected area.
  • Carefully remove the backing from the patch starting at the corner.
  • Apply the sticky side of the patch to the affected area.
  • Use one patch for up to 8 hours.
  • Discard the patch after a single use.

Children under 12 years of age: Consult a physician before use.

Description

DRUG FACTS

Section 42229-5

DRUG FACTS

Section 50565-1

If swallowed, get medical help or contact a Poison Control Center

(1-800-222-1222) immediately.

Section 50566-9

  • Localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling, or blistering.
  • Conditions worsen.
  • Symptoms persist for more than 7 days or clear up and occur again within a few days.

Section 50567-7
  • Use only as directed.
  • Read and follow all directions and warnings on this carton.
  • Avoid contact with the eyes, mucous membranes, or rashes.
  • Do not use at the same time as other topical analgesics.
  • Do not bandage tightly or apply local heat (such as heating pads) to the area of use.
  • Do not microwave.
  • Dispose of used patches in a manner that always keeps the product away from children and pets. Used patches still contain the drug and could produce serious adverse effects if a child or pet chews or ingests them.

Section 50570-1

• On cut, irritated, or swollen skin. • On puncture wounds. • For more than one week without

consulting a doctor. • If you are allergic to any active or inactive ingredient. • If the pouch is

damaged or opened.

Section 51727-6

Acrylic block co-polymer adhesive

Section 51945-4

PediFix

Meidcal Footcare

Lidocain

Pain-Relief

Patches

Relieve Pain Instantly!

Scissor-Trim to Any Size

Water-Resistant

Unscented

4% Lidocaine Topical Anesthetic

Maximum Strength

6

Medicated Patches

Trim to Any Size

Section 53414-9

ask a health professional before use.

Section 55105-1

Topical Anesthetic

Section 60561-8

Store in a clean, dry place outside of direct sunlight. Protect from excessive moisture.


Structured Label Content

Warnings and Precautions (34071-1)

For external use only

Active Ingredient (55106-9)

lIDOCAINE 4%

Indications and Usage (34067-9)

Temporarily relieves minor pain

Dosage and Administration (34068-7)

Adults and children 12 years of age and over:

  • Clean and dry the affected area.
  • Carefully remove the backing from the patch starting at the corner.
  • Apply the sticky side of the patch to the affected area.
  • Use one patch for up to 8 hours.
  • Discard the patch after a single use.

Children under 12 years of age: Consult a physician before use.

Section 42229-5 (42229-5)

DRUG FACTS

Section 50565-1 (50565-1)

If swallowed, get medical help or contact a Poison Control Center

(1-800-222-1222) immediately.

Section 50566-9 (50566-9)

  • Localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling, or blistering.
  • Conditions worsen.
  • Symptoms persist for more than 7 days or clear up and occur again within a few days.

Section 50567-7 (50567-7)
  • Use only as directed.
  • Read and follow all directions and warnings on this carton.
  • Avoid contact with the eyes, mucous membranes, or rashes.
  • Do not use at the same time as other topical analgesics.
  • Do not bandage tightly or apply local heat (such as heating pads) to the area of use.
  • Do not microwave.
  • Dispose of used patches in a manner that always keeps the product away from children and pets. Used patches still contain the drug and could produce serious adverse effects if a child or pet chews or ingests them.

Section 50570-1 (50570-1)

• On cut, irritated, or swollen skin. • On puncture wounds. • For more than one week without

consulting a doctor. • If you are allergic to any active or inactive ingredient. • If the pouch is

damaged or opened.

Section 51727-6 (51727-6)

Acrylic block co-polymer adhesive

Section 51945-4 (51945-4)

PediFix

Meidcal Footcare

Lidocain

Pain-Relief

Patches

Relieve Pain Instantly!

Scissor-Trim to Any Size

Water-Resistant

Unscented

4% Lidocaine Topical Anesthetic

Maximum Strength

6

Medicated Patches

Trim to Any Size

Section 53414-9 (53414-9)

ask a health professional before use.

Section 55105-1 (55105-1)

Topical Anesthetic

Section 60561-8 (60561-8)

Store in a clean, dry place outside of direct sunlight. Protect from excessive moisture.


Advanced Ingredient Data


Raw Label Data

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